BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNERGY

    MDR report key: 15195455 · Received August 9, 2022

    Report

    Report Number
    2134265-2022-08427
    Event Type
    Death
    Date Received
    August 9, 2022
    Date of Event
    July 26, 2022
    Report Date
    November 7, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYNERGY OUS MR 4.50 X 16MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. THE DEVICE WAS RETURNED WITH THE STENT DAMAGED AND DETACHED FROM THE BALLOON. THE STENT OD (OUTER DIAMETER) AT THE TIME OF MANUFACTURING WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED AND NO ISSUES WERE NOTED. A VISUAL EXAMINATION OF THE BUMPER TIP SHOWED SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE KINKS. A VISUAL EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. A PATIENT PREVIOUSLY TREATED A FEW YEARS BACK WITH A DRUG ELUTING STENT (DES) IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) PRESENTED FOR AN ANGIOPLASTY IN THE MODERATELY CALCIFIED DIFFUSED LEFT CIRCUMFLEX (LCX) LESION. DURING THE TIME OF THE GUIDE CATHETER ENGAGEMENT, A LEFT MAIN (LM) DISSECTION WAS NOTED, CAUSING THE PATIENT TO BECOME UNSTABLE. FOLLOWING DEPLOYMENT OF A NON BOSTON SCIENTIFIC DEVICE IN THE LXC, A 4.50 X 16 SYNERGY STENT WAS ADVANCED TO TREAT THE LM TO LAD, BUT THE STENT BECAME STUCK WITH THE STENT PREVIOUSLY IMPLANTED IN THE LAD. THE SYNERGY STENT WAS NOT DEPLOYED. WHILE PULLING BACK THE DEVICE FROM THE LESION SITE, THE STENT DISLODGED FROM THE DELIVERY SYSTEM. A SNARE WAS THEN ADVANCED TO RETRIEVE THE DISLODGED STENT FROM THE VESSEL. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). HOWEVER, THE PATIENT ULTIMATELY PASSED AWAY THE NEXT DAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. A PATIENT PREVIOUSLY TREATED A FEW YEARS BACK WITH A DRUG ELUTING STENT (DES) IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) PRESENTED FOR AN ANGIOPLASTY IN THE MODERATELY CALCIFIED DIFFUSED LEFT CIRCUMFLEX (LCX) LESION. DURING THE TIME OF THE GUIDE CATHETER ENGAGEMENT, A LEFT MAIN (LM) DISSECTION WAS NOTED, CAUSING THE PATIENT TO BECOME UNSTABLE. FOLLOWING DEPLOYMENT OF A NON BOSTON SCIENTIFIC DEVICE IN THE LXC, A 4.50 X 16 SYNERGY STENT WAS ADVANCED TO TREAT THE LM TO LAD, BUT THE STENT BECAME STUCK WITH THE STENT PREVIOUSLY IMPLANTED IN THE LAD. THE SYNERGY STENT WAS NOT DEPLOYED. WHILE PULLING BACK THE DEVICE FROM THE LESION SITE, THE STENT DISLODGED FROM THE DELIVERY SYSTEM. A SNARE WAS THEN ADVANCED TO RETRIEVE THE DISLODGED STENT FROM THE VESSEL. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). HOWEVER, THE PATIENT ULTIMATELY PASSED AWAY THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302380 SYNERGY CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 10618 0026797513

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Unknown Death